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510(k) K965142

VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) by Johnson & Johnson Clinical Diagnostics, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1997
Date Received
December 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

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  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (February 20, 1997)
  • K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDES (February 18, 1997)

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